The Vasculitis and Diabetes study. A pilot randomised controlled trial to determine the feasibility, tolerability and efficacy of metformin in patients with anti-neutrophil cytoplasmic antibody positive vasculitis.

The Vasculitis and Diabetes study An open labelled, pilot randomised controlled trial to determine the feasibility, tolerability and efficacy of metformin in patients with anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000486123

Acronym

VascDiab

Enrollment

Registered

2019-03-25

Start date

2020-02-03

Completion date

2021-02-01

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Vasculitis and Diabetes (VascDiab) study is an open-labelled multi-centre, unblinded, pilot study assessing the feasibility, tolerability and efficacy of metformin in patients treated with corticosteroids with ANCA-associated vasculitis. We hypothesize that metformin, a drug to prevent diabetes, can be used in patients with ANCA-associated vasculitis.

Interventions

Metformin Patients in addition to standard care, will receive metformin 500mg tablet once daily oral if their eGFR is 15-29 ml/min/1.73m2 or metformin 500mg tablet twice daily oral if their eGFR is equal or greater than 30 ml/min/1.73m2. This will continue for 12 months. Metformin concentration will be assessed at 3, 6, 9 and 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria will include the following: age >18 years, non-diabetic patient a clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions [Jenette, 2013], willing and able to participate in all trial investigations for the duration of trial follow-up and ability to provide a written informed consent.

Exclusion criteria

Exclusion criteria will include the following: known diabetes mellitus at the time of diagnosis of ANCA-associated vasculitis (whether on anti-diabetic medications or not), history of anti-diabetic therapy (oral or insulin), estimated glomerular filtration rate (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) < 20ml per minute per 1..73 metres squared BSA (body surface area), unable to consent, pregnancy or breast feeding, current alcohol or other substance abuse and any major illness or comorbidity that may result in death in 12 months as assessed by the treating physician.

Outcome results